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IRCT20240901062926N2 IRCT 2026-07-20 National Hospital & Medical Center Intraoperative Awareness with Dexmedetomidine–Propofol Infusion versus Intravenous Xylocaine–Propofol Infusion in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial RCT Comparison of Intraoperative Awareness with Dexmedetomidine–Propofol Infusion versus Intravenous Xylocaine–Propofol Infusion in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial 2026-04-22 anticipated 100 Complete https://irct.ir/trial/91731 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: none, Randomization description: Eligible patients who provide written informed consent will be randomly allocated in a 1:1 ratio to either the Dexmedetomidine Propofol group (Group D) or the Xylocaine–Propofol group (Group X) using a computer-generated randomization sequence. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened immediately before induction of anesthesia by an anesthesiologist not involved in postoperative outcome assessment. This process will ensure unbiased allocation of participants to the two study groups, Blinding description: This study will be conducted as a single-blinded randomized controlled trial. The participants will be unaware of the treatment group to which they are assigned (Dexmedetomidine–Propofol or Intravenous Xylocaine–Propofol). An anesthesiologist who is not involved in data collection will prepare and administer the study medications according to the randomization sequence. The investigator responsible for postoperative assessment of intraoperative awareness using the Modified Brice Interview and data analysis will remain blinded to the group allocation. The anesthesiologist administering anesthesia cannot be blinded due to the differences in drug preparation and administration protocols. This blinding approach is intended to minimize assessment bias while ensuring patient safety throughout the perioperative period. 0 (exploratory trials) Intraoperative awareness is the unintended recall of events experienced during general anesthesia. It is a rare but serious complication that can result in psychological distress, anxiety, sleep disturbances, and post-traumatic stress disorder (PTSD). Patients undergoing coronary artery bypass grafting (CABG) are at a higher risk of intraoperative awareness because anesthetic doses are often reduced to maintain cardiovascular stability. This study aims to compare the effectiveness of dexmedetomidine–propofol infusion versus intravenous xylocaine–propofol infusion in reducing the incidence of intraoperative awareness in patients undergoing elective CABG.. Intervention group:. Yes - There is a plan to make this available What will be shared: DATA When: 6 month To whom: open access Conditions: educational purpose Where to obtain: National Hospital How to obtain: email Comments: thankful
public Dr Ahmad Tariq
national hospital
lahore Pakistan 2246 +92 307 8625941 drahmed6196@gmail.com National Hospital & Medical Center scientific Dr Ahmad Tariq
national hospital
lahore Pakistan 2246 +92 307 8625941 drahmed6196@gmail.com National Hospital & Medical Center Pakistan Adult patients aged 30–75 years. Patients of either gender.Patients scheduled for elective isolated Coronary Artery Bypass Grafting (CABG) under general anesthesia American Society of Anesthesiologists (ASA) physical status III or IV.Left ventricular ejection fraction (LVEF) ≥35% Patients who are able to understand the study protocol and provide written informed consent. Patients who are able to communicate postoperatively and complete the Modified Brice Interview. 30 years 75 years Both Patients undergoing emergency CABG surgery.Patients scheduled for combined cardiac procedures (e.g., CABG with valve replacement or other cardiac surgeries).History of previous cardiac surgery (redo CABG).Known hypersensitivity or contraindication to dexmedetomidine, propofol, lidocaine (xylocaine), or any study medication.Pre-existing neurological disorders (e.g., stroke with cognitive impairment, epilepsy, dementia) or psychiatric illnesses that may interfere with the assessment of awareness.Chronic use of sedatives, opioids, alcohol, or recreational drugs.Severe hepatic dysfunction (Child–Pugh Class C) or severe renal impairment requiring dialysis.Significant conduction abnormalities (e.g., second- or third-degree atrioventricular block without a permanent pacemaker) or severe bradycardia (heart rate <50 beats/min).Patients requiring preoperative mechanical ventilation or intra-aortic balloon pump support.Patients with hearing impairment, language barriers, or inability to participate in postoperative interviews.Pregnant or lactating women. Y93 Activity codes Early detection Intervention group: Intraoperative awareness, assessed using the Modified Brice Interview conducted at 24 hours and 72 hours after surgery. Patients reporting explicit recall of intraoperative events will be considered to have experienced intraoperative awareness. Timepoint: 24 hour and 72 hours. Method of measurement: Modified Brice Interview Interpretation0 No intraoperative awareness (no explicit recall of intraoperative events).1 Possible intraoperative awareness (uncertain or vague recall requiring further evaluation).2 Definite intraoperative awareness (clear explicit recall of intraoperative events).Interpretation:0: No awareness1: Possible awareness2: Definite awareness. National Hospital & Medical Center Approved 2025-05-25 NATIONAL HOSPITAL & MEDICAL CENTER national hospital lahore Punjab Pakistan